Cell Pathways to Distribute Gelclair to Oncologists in North America; Product for Oral Pain Recently Cleared by FDA for Marketing in US.

Business Editors/Medical Writers

BIOWIRE2K

HORSHAM, Pa.--(BW HealthWire)--Jan. 23, 2002

Cell Pathways, Inc. (Nasdaq:CLPA) today announced the signing of an agreement with Sinclair Pharma Ltd. (Sinclair) of Godalming, Surrey, England to become the exclusive distributor of Gelclair(TM) Concentrated Oral Gel in North America. Cell Pathways plans to promote Gelclair(TM) initially in the oncology market for use in inflammation and ulceration of the mouth (referred to as mucositis or stomatitis) caused by chemotherapy or radiotherapy using its dedicated sales force. Cell Pathways also plans to seek a partner to promote Gelclair(TM) within oral surgery and other dental markets.

The U.S. Food and Drug Administration (FDA) granted 510(k) clearance to market Gelclair(TM) in December 2001 for use in the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. These applications include oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy), irritation due to oral surgery and traumatic ulcers caused by braces or ill-fitting dentures or disease. Gelclair(TM) is also indicated for treatment of diffuse aphthous ulcers. The product, which is a clear viscous gel, is applied by rinsing in the mouth for a short period of time, forming a coating over the mucosal surface of the mouth and thereby soothing the pain and discomfort from oral lesions.

Cell Pathways will make an initial payment and commitments to purchase inventory from Sinclair in calendar year 2002, totaling five million dollars. The term of the agreement is 10 years with provision for extension under certain circumstances. The company will purchase product from Sinclair Pharma Ltd. pursuant to forecasts to be adjusted from time to time subject to minimum purchase requirements. Under the agreement, Cell Pathways will become the exclusive distributor for the United States, Canada and Mexico. Sinclair is responsible for filing applications for marketing approval of Gelclair(TM) in Canada and Mexico.

"We are very pleased to be the exclusive distributor of Gelclair(TM) for North America, and plan to introduce this product in the U.S. oncology marketplace during the second quarter of 2002," said Robert J. Towarnicki, Cell Pathways chairman and chief executive officer. "The addition of Gelclair(TM) allows our sales force to broaden our presence in the oncology marketplace and provides patients afflicted with oral mucositis an effective, well-tolerated and easy-to-use treatment. Additionally, we believe the opportunity for this product in the dental marketplace may be comparable to that in oncology, and we plan to explore arrangements that will allow us to distribute Gelclair(TM) into this market."

"Of equal importance is the addition of this product to our business strategy," he added, "that of marketing products in oncology as a way to build revenues as we continue the ongoing development of our selective apoptotic antineoplastic drugs (SAANDs). In particular, we look forward to expanding our development program for CP461 in the months to come, as early clinical data suggests this experimental drug has biological activity in humans in both hematologic and solid tumor cancers." Cell Pathways is currently studying CP461 as a single-agent therapeutic in ongoing Phase IIa trials in chronic lymphocytic leukemia (CLL), renal cell carcinoma and hormone-refractory prostate cancer.

"We are pleased to select the Cell Pathways' dedicated oncology sales force as our marketing partner for promotion of Gelclair(TM) within the North American markets," said Dr. Michael Flynn, chief executive officer of Sinclair. "We chose Cell Pathways for this important product introduction based on their demonstrated success in promoting Nilandron(R) to oncologists and urologists treating prostate cancer patients, and for their knowledgeable and experienced oncology sales team."

Oral Mucositis and Gelclair(TM)

Oral mucositis is an inflammation and ulceration of the lining of the mouth and throat most commonly associated with chemotherapy or radiotherapy for cancer. Patients often identify oral mucositis as the most unpleasant side effect of cancer therapy. Symptoms of oral mucositis may include ulcerations, redness, and swelling in the mouth. More severe side effects include extreme pain that may prevent the patient from eating and necessitate hospitalization and total parenteral nutrition, serious risk of infection and the interruption of cancer therapy.

Experts estimate that approximately 300,000 cancer patients in the United States suffer from oral mucositis associated with cancer treatment. Oral mucositis also affects almost all patients receiving radiation therapy for head and neck cancer as well as patients receiving radiation therapy in the upper half of the chest.

In an open-labeled trial where all patients were treated with Gelclair(TM), the patients reported on average a 92% reduction in total oral pain within 5-7 hours and, after one week of treatment, 87% of patients reported overall improvements related to pain on swallowing food, liquids and saliva.

About Sinclair Pharma Ltd.

Sinclair Pharma Ltd., headquartered in Godalming, Surrey, England, is an ethical pharmaceutical company that acquires and develops niche products and commercializes them through an international network of marketing partners. Sinclair expects to develop a number of line extensions and new products principally in oncology and oral health.

About Cell Pathways, Inc.

Cell Pathways, Inc., headquartered in Horsham, Pa., is a development stage pharmaceutical company focused on the research, development and commercialization of novel and unique medications to prevent and treat cancer. Cell Pathways currently markets Nilandron(R) (nilutamide) to urologists in the United States and Puerto Rico. Nilandron(R) (nilutamide) is a hormonal therapy manufactured by Aventis Pharmaceuticals, Inc. which blocks the production of testosterone in men with advanced prostate cancer.

Gelclair(TM) will become the second product marketed by Cell Pathways, broadening Cell Pathways' presence in the oncology-related marketplace. For additional information on Cell Pathways, Inc., visit the company's web site at www.cellpathways.com.

Certain statements made in this release, and oral statements which may be made with respect to this release, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are those which express plan, anticipation, intent, contingency or future development and/or otherwise are not statements of historical fact. These statements are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Such risks and uncertainties relate to, among other factors; the absence of experience marketing the product Gelclair(TM) and the risk that physicians, oral surgeons, and dentists do not prescribe the product and sales do not materialize, the risk associated with the product launch, including manufacturing and marketing risks; the risk that the company's sales of Gelclair(TM) are less than the minimum purchase obligations under the agreement; the absence of approved products developed by the company; history of operating losses and the need for further financing; early stage of development; the costs, delays and uncertainties inherent in scientific research, basic pharmaceutical research, drug development, clinical trials and the regulatory approval process, with respect to both our current product candidates and our future product candidates, if any; dependence on the development and market acceptance of one or more of our product candidates for one or more significant disease indications; the risk that the company does not conduct the clinical studies it may have planned to conduct or does not pursue development plans it may have planned to pursue; uncertainty that additional studies, if any, may not be positive; limitations on, or absence of, the predictive value of data obtained in laboratory tests, animal models and human clinical trials when planning additional steps in product development; uncertainty of obtaining regulatory approval of any compound for any disease indication whether due to adequacy of the development program, changing regulatory requirements or otherwise; the risk that the FDA will stop or further delay the Phase III lung cancer study or any other study as a result of safety or otherwise; the risks that clinical studies do not result in the safety and efficacy necessary to obtain regulatory approvals; the risks of conducting clinical trials of our drugs in combination with other drug therapies; the commercial risk and risk of liability in promoting Nilandron(R) (nilutamide) manufactured by Aventis Pharmaceuticals and Gelclair(TM) manufactured by Sinclair Pharma, Ltd.; the risk that the Company may enter into, or may fail to enter into, licensing, partnership or other collaborative arrangements which accord to other companies rights with respect to one or more Company compounds or in which the Company acquires new rights and obligations; the volatility of the market price of our common stock; our ability to sell securities registered under the shelf registration statement; acceptance of any product candidates by physicians and providers of healthcare reimbursement; the actions of competitors; the pace of technological changes in the biopharmaceutical industry; dependence upon third parties; the validity, scope and enforceability of patents; the risk of our pending class action securities litigation; potential product liability claims; and availability and adequacy of insurance. These and other risks are detailed in our reports filed from time to time under the Securities Act and/or the Securities Exchange Act, including the sections entitled "Business," "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Other Events" in our annual reports on Form 10-K, quarterly reports on Form 10-Q and periodic reports on Form 8-K and in such registration statements on Form S-3 as we may file from time to time. You are encouraged to read these filings as they are made. They are available over the Internet from the SEC in its EDGAR database at http://www.sec.gov and from the Company. Given the uncertainties affecting pharmaceutical companies in the development stage, you are cautioned not to place undue reliance on any forward-looking statements, any of which may turn out to be wrong due to inaccurate assumptions, unknown risks, uncertainties or other factors. No forward-looking statement can be guaranteed; actual future results may vary materially. Both forward-looking statements and statements of historic fact must be understood in the context of the risks referred to above which characterize our development-stage business. We undertake no obligation to update or revise the statements made herein or the risk factors that may relate thereto.

Note to Editors: Gelclair(TM)is a trademark of Sinclair Pharma, Ltd. Nilandron(R)is a trademark of Aventis Pharmaceuticals, Inc.